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AstraZeneca Says Brilinta Beats Plavix in Clinical Trial
May 12, 2009
Another story that lets a drug company get away with making superiority claims without releasing data. News organizations that give industry such a platform are not going to get a pass from us.
Our Review Summary
As the individual ratings illustrate, this story on the release of partial results of a trial of a new anti-clotting drug, Brilinta, falls short of several best practices of health journalism. Most importantly:
- It fails to discuss costs and treatment alternatives
- It fails to include medical sources who could provide a useful reality check about potential clinical applications of the new drug compared to the incumbent--and to non-drug or other treatments.
Having said that, the reporter does a passable job of providing caveats about the limitations of the released data, and about how efficacy and safety have not yet been proven.
This story was obviously written for a business audience more focused on drug development than in clinical applications. It appeared in the business, not the lifestyle section of the Wall Street Journal. Yet the news has implications for consumers concerned about current and coming treatments for serious heart conditions. The story should be judged at least partly based on its value--or lack thereof--to a general reader.
This is especially true in an age where stories written for print often reach more readers online, where there is no "section" context. When a story like this pops up on Google news or some other directory, readers do not know to expect a lower level of relevance and service because of the audience for which it was originally intended.
Judged by these standards, as the ratings show, this story falls far short.
It's worth noting that the Wall Street Journal's Health Blog featured an entry on the Brilinta study that in significant ways is superior to the newspaper's report--expressing greater caution about interpreting the results and the unclear status of the drug's efficacy and safety. Presumably the WSJ Health Blog is aimed at an audience similar to the newspaper's.
This raises fascinating questions about journalism in the digital age:
- Do the mannerisms of writing "articles" constrain the writer from leveling with readers?
- Is blog journalism superior to the standard kind, occasionally or frequently?
- Do the layers of editing a print story is subjected to add or diminish reader value?
- Is the doom and gloom about a news environment where most information is delivered via blogs and other sort- and fast-form content types warranted?
- What if professional journalists writing in blogs actually served the public better than their ink-and-paper-bound peers?
Click on Criteria for definitions.
The story makes clear that Brilinta is not yet available. It says the company plans to submit the drug for approval in the fourth quarter of this year.
Wisely, the reporter resists predicting when the drug might be on the market, since this is not guaranteed.
The story fails to discuss the new drug's cost or even cite the price of its chief competitor.
It may be difficult to project a drug's cost before it's on the market. But these drugs are expensive [Plavix, the incumbent anti-clotting blockbuster, is $4 per day] and readers should realize that.
Because the story focuses on the potential of Brilinta to knock off Plavix, some discussion of price should have been included. The economic stakes are high not only for the industry, but for the public and individual consumers.
The story does not exaggerate the dangers of any of the heart conditions the anti-platelet drugs are designed to treat.
The evidence of the drug's efficacy and safety is being withheld by the company, and won't be released until August at a cardiology conference.
The story discloses this, and quotes unnamed "analysts" warning that until the data are released and side effects known, approval should not be assumed.
Given this disclosure, the story earns a "Satisfactory" rating under this criterion.
The story fails to mention the potential harms of Brilinta.
Given the questions about risks of the reigning anti-platelet blockbuster Plavix it intends to replace, this is a significant omission.
- Previous research has found that patients who take Plavix after receiving stents face elevated risks if they quit taking the drug.
- Just a week prior to this report, new unpublished research verified previous work showing a seriously elevated risk of adverse heart events for those who take Plavix along with a proton pump inhibitor, a commonly prescribed drug type for GERD/heartburn.
The risks linked to Plavix could therefore arguably demonstrate a need for a drug that reduces heart risk without introducing other potential harms.
This should have been mentioned, as should have any potential risks early data link to Brilinta.
The story states that analysts claim that Brilinta's effects appear to be more reversible than Plavix's, which would be useful in helping heart patients prepare for heart procedures involving surgery, where a risk of bleeding is very serious. But that's almost a worthless claim and clause in the story. Science - and evidence - not analysts - should establish novelty.
The story describes the study as "unusually large," invovling 18,600 patients with acute coronary syndromes. It describes the trial as a head-to-head comparison between Brilinta and Plavix and specifies the clinical end points used in the research.
The story cites the company's description of the results as "statistically significant" in a way that favors Brilinta over Plavix.
Given the fact that little additonal data has been released [see the company's press release on the early Brilinta results], the story earns a "Satisfactory" rating under this criterion.
We can't be sure of the source of the information. No independent source is quoted. There are only brief references to what analysts say.
All information in the story appears to come from company sources, though no one is quoted by name. [Other press coverage of the AstraZeneca statement fails to include additional comments from company spokesmen, suggesting the company did not provide more information to anyone.]
Unnamed "analysts" are said to urge caution about the drug's market value until the results are published and information about side effects is known.
But the elephant absent from the room is the medical expert who could provide insight into Plavix's risk/benefit profile, how significant its risks are from a clinical perspective, and what value Brilinta would have if indeed it provides better outcomes and its effects are more quickly reversible.
It's significant to note that this medical information would be useful not just to consumers, but to Wall Street Journal readers who follow AstraZeneca's fortunes and who participate in the bloodsport of betting on drug blockbusters.
The story takes the viewpoint of the study, which is a head-to-head trial comparing Brilinta against Plavix.
Readers should know how these expensive drugs perform relative to the cheaper, older alternatives, which include aspirin and warfarin.
It should also describe results for those who use non-drug treatments after getting stents or experiencing other conditions for which anti-platelet medications are used.
Total Score: 4 of 9 Satisfactory
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The website NoFreeLunch.org posts "a database of health care professionals who have pledged to accept no gifts from industry and to rely on non-promotional sources of information."
To help journalists cover stories responsibly, we post a list of independent experts who state that they do not have financial ties to drug or medical device manufacturers.
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